Staff Manufacturing Systems Engineer

Recor Medical•Palo Alto, CA

19h

About The Position

This role involves the design of complete and complex acoustic systems. This requires functional development and integration of the software, hardware and mechanical aspects of product, systems, and components to ensure that the resulting functionality meets the device performance requirements of the acoustic system.

Requirements

Master of Science degree in Biomedical / Computer Science Engineering with experience in medical device industry.
Experience with microcontroller programming.
Experience with MATLAB, Python, C++, other similar tools for software development and instrument control.
Work with measurement systems such as function generator, oscilloscope, radiation force balance, hydrophone, motor systems to characterize complex acoustic and temperature fields.
Identify problems or improvement opportunities in existing measurement methods, and system/transducer designs.
Excellent oral and written communication skills.
Self-motivated, action oriented and result oriented.
Understanding of medical device processes and assembly knowledge to drive product yield and performance.
Experience with cybersecurity requirements for medical device or manufacturing systems, including secure software development, risk assessment, access control, vulnerability management, and familiarity with FDA cybersecurity expectations, IEC 81001-5-1, and IEC 62443.

Responsibilities

Leads development of computer programming systems and applications including the design, coding, testing and deployment of products and solutions to meet production needs.
Develops software and hardware that communicates with variety of microcontrollers / devices using ethernet, serial, One Wire, I2C protocols etc
Create a robust open-source software framework and solution for systems used in production line.
Execute test method validation to develop software requirement specification with cross functional agreement.
Generating and executes test plans, verification, and validation protocols.
Research and implement new methods and technologies to enhance operations.
Assists process development in developing scalable processes with improved product yield and reduced costs for manufacturing systems.
Working independently to identify and drive production capacity improvements by providing automation solutions.
Develop medical device software by being compliant with IEC and other pertinent regulatory medical device standards.
Integrate cybersecurity requirements into manufacturing software, hardware, and networked systems to support secure design, deployment, and maintenance of production equipment and test systems.
Apply secure software development and change control practices, including cybersecurity documentation, verification, and traceability, in alignment with FDA expectations and applicable standards such as IEC 81001-5-1 and IEC 62443.
Support vulnerability monitoring, patch evaluation, incident response, and remediation activities for manufacturing systems while minimizing disruption to validated production processes.
Collaborate with Quality, IT, Regulatory, and R&D teams to maintain cybersecurity compliance, support audits, and promote cybersecurity awareness and best practices across production operations.
Systematically analyze and solve complicated problems through electrical/acoustic/mechanical testing.
Design test methods/procedures to characterize the electrical and acoustic system performance.
Work with measurement systems such as function generator, oscilloscope, radiation force balance, hydrophone, motor systems to characterize complex acoustic and temperature fields.